NCT03536182撤回3 期
CIPHER: A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion Versus Conventional Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Over all Survival
研究概览
简要总结
To determine if carbon ion radiotherapy improves overall survival versus photon therapy in patients with locally advanced, unresectable pancreatic cancer
详细描述
To compare the efficacy of carbon ion-based chemo radiotherapy with x-ray-based chemo radiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival at 2 years following treatment.
Patient has 2 in 3 chance of receiving Arm A and 1 in 3 chance of receiving Arm B.
Arm A (chemoradiation takes place in Japan):
CIRT in 12 fractions/treatments plus concurrent gemcitabine, followed by 4 cycles of gemcitabine + nab-Paclitaxel, or until progression or intolerance of therapy
Arm B:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be willing and capable to provide informed consent within the 30 days prior to registration to participate in the protocol.
- •Histological and/or cytological diagnosis of pancreas adenocarcinoma must be done at any point prior to registration
- •Unresectable by radiographic or exploration within 30 days of registration
- •Age ≥ 18 years.
- •Distance from the pancreas tumor edge to the bowel and stomach > 3 mm (in both the prone and supine positions)
- •Tumor does not exceed 15 cm in greatest dimension
- •No evidence for metastatic disease as assessed by CT imaging of the chest, abdomen and pelvis OR by PET-CT within the 30 days prior to registration. Pancreas-protocol CT or magnetic resonance imaging (MRI) with gadolinium (for patients who cannot receive CT contrast) is required as part of this evaluation.
- •Zubrod performance status of 0-1, within 30 days prior to registration.
- •Adequate hematologic, renal, and liver function as defined by:Adequate hematologic, renal, and liver function as defined by:
- •Absolute neutrophil count > 1500 cells/mm3 Creatinine <1.5 mg/dL Hemoglobin ≥ 8.0 g/dL AST and ALT < 2.5 X ULN Bilirubin ≤ 1.5 times the ULN (after stent placement, if necessary)
- •Patients must complete all required pretreatment evaluations
- •Able to travel to a foreign country within approximately 4 weeks of randomization (for patients enrolled outside of Japan and Italy)
- •If a patient receives 1 or 2 cycles of chemotherapy at an outside facility, pre-treatment laboratory values must meet the above criteria. If the protocol-compliant imaging had not been obtained prior to chemotherapy, they may be performed prior to registration and any additional chemotherapy being infused.
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
排除标准
- •Subjects receiving other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study.
- •Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- •Prior radiation to the upper abdomen
- •Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
- •Body weight >100 kg
- •Active inflammatory bowel disease or active gastric/duodenal ulcer
- •Metal implants in the upper abdomen
- •Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy.
- •History of HIV or hepatitis B or C
结局指标
主要结局
Over all Survival
时间窗: 2 Years
To compare the efficacy of carbon ion-based chemoradiotherapy with x-ray-based chemoradiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival following treatment.
次要结局
- Progression-free survival(2 Years)
- Patterns-of-failure(2 years)
- Quality-of-life Comparison(12 Months)
- Toxicity using CTCAE 5.0(2 years)
研究者
David Sher
Professor
University of Texas Southwestern Medical Center
研究点 (4)
Loading locations...
相似试验
Unknown
2 期
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate CancerMetastatic Prostate CarcinomaNCT02935023Shanghai Proton and Heavy Ion Center47
招募中
Unknown
Outcomes of carbon ion radiotherapy and photon stereotactic body radiotherapy using Cyberknife for uveal melanomauveal melanomaJPRN-UMIN000053540ational Institute for Quantum Science and Technology380
招募中
3 期
Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT02610010Sun Yat-sen University462
招募中
2 期
Clinical Study of Carbon Ion Radiotherapy Combined With Chemotherapy for Thymic Epithelial TumorsCarbon Ion Radiotherapy, Thymoma, Thymic Carcinoma, Radiotherapy, ChemotherapyNCT06186726Jian Chen48
招募中
2 期
A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical CancerCervical CancerNCT06251388West China Second University Hospital50